Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.

Reporting Groups

Description

EFV, FTC/TDF, and Placebo ABC/3TC

Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

EFV, Placebo FTC/TDF, and ABC/3TC

Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC

Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC

Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

EFV, FTC/TDF, and Placebo ABC/3TC

Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

EFV, Placebo FTC/TDF, and ABC/3TC

Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC

Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC

Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Time From Treatment Dispensation to a Grade 3/4 Safety Event [ Time Frame: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks. ]

Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Number of Participants With Virologic Failure and Emergence of Major Resistance [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Only fasting results are included. The protocol did not require that samples be collected fasting.

Time Frame

At Weeks 48 and 96

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Reporting Groups

Description

EFV, FTC/TDF, and Placebo ABC/3TC

Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

EFV, Placebo FTC/TDF, and ABC/3TC

Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC

Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC

Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.